NCT00205816已完成3 期
An Open-label, Noncomparative, Multi-center, Emergency Use Protocol Administering Tigecycline for the Treatment of Subjects With Infections Due to Resistant Pathogens.
Wyeth is now a wholly owned subsidiary of Pfizer3 个研究点 分布在 2 个国家目标入组 26 人开始时间: 2004年1月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 26
- 试验地点
- 3
- 主要终点
- response
研究概览
简要总结
The purpose of this study is to provide a mechanism for the emergency use of tigecycline in the appropriate clinical situations.
The secondary objective is to evaluate the safety and efficacy of tigecycline in the treatment of patients with selected serious infections where other treatment has not been successful.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects, greater than 8 years of age and a weight of more than 35 kilograms.
- •Patients with current bacterial infections who have not responded to other available appropriate antibiotic therapies.
- •Patient must give informed consent.
排除标准
- •Patients with an expected survival of less than 2 weeks.
- •Patients who have been designated as "Do Not Resuscitate".
- •Known or suspected hypersensitivity to tigecycline, tetracyclines, or other compounds related to this class of antibacterial agents.
- •Pregnant women or nursing mothers.
结局指标
主要结局
response
次要结局
- micro response at subject level
- micro response at pathogen level
- clinical response at pathogen level
- development of decreased susceptibility
研究者
研究点 (3)
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